Medical device recalls Moderate risk

Sunrise Medical (US) LLC recalls Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisti…

Recall date
July 8, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2157-2021
FDA classification
Class II
Brand / firm
Sunrise Medical (US) LLC
Sold / distributed
Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. T…

Why it was recalled

The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.

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